After suspending an ice cream company’s food facility registration in late 2018 during a  foodborne illnesses investigation, the FDA is allowing Working Cow Homemade Inc. to reopen, but not as a manufacturer.

The company, in St. Petersburg, FL, is now an ice cream warehouse business, according to a notice from the Food and Drug Administration.  The company is allowed to store and distribute products from third-party manufacturers. The FDA notice did not include information about what brands the Working Cow company will be handling.

“The FDA’s decision to suspend the registration of Working Cow Homemade Inc. was prompted by the three cases (of listeriosis) and findings from the FDA’s 2017 and 2018 inspections of Working Cow Homemade Inc., which identified insanitary conditions that could lead to contamination with Listeria monocytogenes (L. mono) in finished products,” according to the agency’s notice.

Inspectors from FDA worked with the Centers for Disease Control and Prevention, the Florida Department of Health and the Florida Department of Agriculture and Consumer Services on the investigation.  

Prior to the suspending the company’s registration in late 2018, the FDA inspected the Working Cow production facility from Aug. 29 to Sept. 1, 2017. During that inspection, inspectors collected environmental samples from the facility, which resulted in a recall and commitments by the firm to implement corrective actions. 

“In September 2018, the Centers for Disease Control and Prevention contacted the Florida Department of Health after finding that the pathogen analyses of three clinical cases — two in 2013 and one in 2018 — of listeriosis were highly related to the pathogen analyses of 2017 environmental samples taken by the FDA at the production facility,” according to the FDA notice.

“based on this information, the FDA conducted a follow-up inspection of the facility from Sept. 25 through Oct. 15, 2018. Whole Genome Sequencing (WGS) conducted by the FDA identified that the L. mono isolates collected from three ill patients were genetically identical to the L. mono isolates taken from environmental samples in the Working Cow facility in 2017 and 2018.”

After the 2018 inspection, the FDA provided Working Cow Homemade Inc. with several inspectional observations on a Form 483 report, noting sanitation and production issues. The FDA reported that Working Cow owners had not provided evidence of implementing corrective actions the firm committed to in response to the 2017 inspection and did not have information or documentation for the firm’s food safety plan including developing written sanitation practices, required by FSMA. 

“based on these observations, ready-to-eat (RTE) ice cream products manufactured, processed, packed, received or held at the Working Cow facility have a reasonable probability of causing serious adverse health consequences or death. The risk of illness and/or death from L. mono is particularly serious for the elderly and immunocompromised, which is concerning because Working Cow sold around 40 percent of its products to nursing homes and assisted living facilities,” the FDA reports.

On Oct. 18, 2018, Working Cow expanded a previous recall to include all ice cream it manufactured from Aug. 29, 2017, through Oct. 11, 2018.

Company owners decided to stop producing ice cream and become a distribution firm instead. They provided business plans to the FDA, requesting that the agency lift its registration suspension.

“Given the proposed changes and commitments by the firm, along with FDA site inspection and verification, the FDA has lifted the suspension, reinstating the facility registration for Working Cow Homemade Inc.,” according to the agency.